Richard Burr: quorum call: mr. burr: mr. president? senator from north carolina. mr. burr: the senate is of the -- the presiding officer: the national is in a quorum mr. burr: i ask unanimous consent to vitiate the quorum call. the presiding officer: without objection. mr. burr: mr. president, while

Richard Burr: the senate is in consideration of a bill to regulate tobacco think it's extremely important that the members of the b understand that tobacco is not and let saying, i'm not proposing that

Richard Burr: we don't do something additionally in the united states senate. i think we can with regulate more effectively. but what i've put up -- and i know it's hard for the president to see -- what i've put up is the current regulatory structure of the tobacco industry in america. it shows every federal agency that currently has a regulatory

Richard Burr: jurisdiction over tobacco. the department of transportation, the department of treasury, the department of commerce, the department of justice, the executive office of the president, the department of health and human services, the department of education, the department of labor, general services administration, the g.s.a., the department of veterans afairks federal trade commission, department of agriculture, the environmental

Richard Burr: protection agency, the u.s. postal service, and the department of defense. that currently today regulate the product of tobacco. so for any person to come to the floor of the united states senate and claim that there's not sufficient regulation of this industry right now is ludicrous. as a matter of fact, this is the

Richard Burr: most regulated product sold in the united states of america currently. now, the proposal that senator kennedy proposal to concentrate regulation of tobacco in the food and drug administration, a agency that was created for the sole purposes by their mission

Richard Burr: statement of approving safetynd efficacy of drugs, biologic cosmetics, products that emit radiation and responsibility for food safety. so we're going to shift from all the federal agencies and the flowchart underneath them from different aspects of r

Richard Burr: for the tobacco industry and concentrate this in the food and drug the-it probably makes a lot of sense as far as consolidation but i want my colleagues to understand this truly today is the most regulated product sold in america when you look at the

Richard Burr: expanse of this regulation, regulatory framework we have today. the authors of the bill have suggested that we have to allow the f.d.a. to have jurisdiction because there should be two objectives. one is to reduce death and

Richard Burr: disease; and two is to reduce usage of tobacco products -- two goals i embrace wholeheartedly of the let me share with m colleagues this it starts with a product that i consider to be of these products present a health risk. what's the problem, cigarette.

Richard Burr: i know the president of senate probably rembers when all of his friends smoked nonfilterred cigar truth is we rebel still have some friends that and the risk, the continuum of risk goes down in the next category is filtered cigarettes. the industry introduced filtered cigarettes at some point

Richard Burr: probably before i was and as you can see, the risk only reduced by 10%. it meant that there was 10% less likely to have a risk involved in but, still, carly, 90% of users having the risk is pretty

Richard Burr: unacceptable. and then we go to a category that never really hit the market except for market testing. that was cigarettes, a product that didn't actually burn tobacco but it had a disk in the front and that disk glowed and got hot and as that hot air was pulled to

Richard Burr: then a new category of product called electronic fascinating product, rather expensive, runs off a bat dry battery and it extracts the nicotine in a different way than the tobacco-heated cigarette but clearly you see that in two

Richard Burr: advantageous opportuni people who used nonfilterred cigarettes. if we could get them over here we have, one, reduced the risk of death; and we have reduced the risk of disease. now let me move out to this next category which is smokeless tobacco. u.s. smokeless tobacco. i need to draw that distinction

Richard Burr: because types of but u.s. smokeless tobacco all of a sudden reduces the risk 10%. we've reduced by 90% presented by the products. now we move to the next category which is probably hard for the

Richard Burr: products that deliver the nicotine need to allow somebody to go from a nonfilterred product all the way over here to a u.s. smokeless or to a swedish smokeless stuff. and we have gone from 100% risk to 2% or 3% risk. now a new category not even on the mart and a category that's

Richard Burr: already been product that shouldn't dissolvable tobacco, a product that dissolves in one's mouth, that needs over here from a stanoint of being addicted to nicotine but puts the category of risk somewhere down in the category.

Richard Burr: i think the president sort of understands where i'm going. as innovation has tak we've allowed the opportunity for people to come off of products that had 100% risk down to products that reduced the risk by 99% and then we have therapeutics like gum and

Richard Burr: patches and pharmaceutical products with minimum risk allowing people to actually either ruce or quit the habit of tobacco usage. so when you look at the goal of a tobacco bill and the authors have said the goal

Richard Burr: disease, death, and youth use acknowledge, i ask the president of the senate if you reduce from 100% the risk, to 10% for u.s. smokeless smokeless, does that embassy the spirit or intent of what the -- does that embrace the spirit or intent of what the author is trying to do?

Richard Burr: i say yes. but this category that is at 2% under the country will that's being considered by the united states senate would be banned. why? because of an arbitrary date they have chosen to say if the product wasn't sold in the united states bef 2002 then this produ is not

Richard Burr: alwed to stay on the marketplace. so my point is this, mr. president: say the objective of the legislation is to reduce the risk as you reduce the risk you reduce the likelihood of disease, the severity of death, isn't this the categories that

Richard Burr: we move to? i think the answer is obvious to the american people. it's yes. welwe would like to r costs, reduce death and if we can do that by bringing this new aim of products to the marketplace, this is beneficial to everybody.

Richard Burr: it makes a lot of sense. that's not what the legislation does. i've spent this day coming to the floor trying to emphasize with my colleagues that what the legislation in fronts o front of the united states senate does, it grandfathers non cigarettes and filtered cigarettes. it says these are the only

Richard Burr: products that are going to be allowed to stay on the market. it means 2 have chosen to smoke, hopefully adults, are locked into these categories from a standpoint of choice. yetn sweden, they created this new product over here and they have had this massive movement of people from these categories to

Richard Burr: this is not something i have made up, the data is there to show. now, the authors of the bill currently under consideration on the senate floor would suggest, well, we allow this product to be created. and there are three t they have to meet. i would tell you the three threshholds they have set are

Richard Burr: absurd. they can't be met. let me just focus on the third threshhold. ey suggest that the manufacturer would have to prove that this used by a nontobacco user. well, for you t accumulate the

Richard Burr: data to know if a nontobacco user is interested in using the product you have to present the product to them and explain it before they could comment on whether they would be inclined to want to try it. but the bill forbids any communication about a product that hasn't been approved. so i ask, how do you get a product approved if the

Richard Burr: threshhold is to tell them what the likelihood is of people who haven't used tobacco products using it if you can't talk to people who haven't used tobacco products about using the product, because the product hasn't been approved? in washington, d.c. we call this a crafty but reversing, in the bill, the

Richard Burr: ability to use it. so in essence, the bill that's under consideration creates these two cat gores indefinite -- cat gores indefinitely and i okay if 20% of the american people choose to use those products and hopefully over times most will not ooz them but we -- not use them but that 20% are using them and they

Richard Burr: will die or have severe disease. well, if that's the case, how can you come out and claim this is a public health bill, that we're going to because of the responsibilities that we have to public health? you 1998 smoke rat dropped from approximately 23.5%

Richard Burr: 2016 the rate of america will drop to 15.7%. but if you look at the congressional budget office that had an opportunity to see the kennedy bill they estimate t kennedy bill 2% or the meaning in 2019 the rate will

Richard Burr: fall from 19.5% to 17.5%. you get where i'm going? by giving the f.d.a. regulatory authority we're going to increase by over of smokers in the country than if we did nothing. it doesn't make much sense, does it? well, let me explain.

Richard Burr: weapon you lock categories and you eliminate the ability for somebody who is a smoker to find one of these oducts to move to, you have now locked in the category of smokers. when you explain it to somebody this makes tremendous sense. the question is: why would we do in

Richard Burr: i would expect arguing this ishe right strategy but they are progressive, because they are focused on the healt and the fact doing this because o death and disease really isn't true. we're doing years ago somebody wanted to do something punitive to an industry. as a matter of fact,

Richard Burr: mr. president, i claim to you that because the date that's set in the kennedyill is february 2007 -- so if the product wasn't sold before 2007 -- it is banned from the marketplace. they wouldn't

Richard Burr: bill they passed out of committee in 2007 to reflect 2009 which is the cur there was so little attention paid to this piece of legislation that they didn't even go through to purge the date and to change it, they just printed the same page of the bill they had last now, i've said several

Richard Burr: throughout this debate the only thing i ask members to do before they vote on this bill is read it. i don't think that's too much to ask if you read the bill you will never vote for the by. if you read the bill you will understand that, one, this a lot of sense;

Richard Burr: the authority to the food and drug administration, an agency that's never, you might remember when i wen regulatory structure i mention the food and drug administration. i did mention the department of health and human services. as you go down things under the health and

Richard Burr: human services, there's no f.d.a. we're choosing an agency of the federa regulated tobacco. how can that possibly make sense? maybe if you claimed going to put it at the centers for disease control they actually have some responsibility within the framework currently of regulating tobacco but not the f.d.a.

Richard Burr: we may have taken the only piece of the federal government that doesn't currently have any jurisdictional responsibilities to regulate tobacco and we're giving them 100% of the requirements to regulate tobacco. the truth is, we don't need the f.d.a. to do we can do it entity under the secretary of

Richard Burr: health and human services, the same person that's over the f.d.a. today and we would suggest doing that by new center. that new responsible to regulate in total tobacco industry. and center.

Richard Burr: think about that. harm reductionst. let me go back the continuum of risk. if the objective is to reduce death got to drive the risk down. to to drive the risk down, you've got to bring products to the marketplace. so you've got two choic.

Richard Burr: you've got a bill that will do that through creating a harm reduction center that with all of the authority that the f.d.a. has, or choose the kennedy bill, which basically isolates these categories of 100% risk and 90% risk and you put statute that the f.d.a. can't touch products that are over

Richard Burr: here but, more importantly, structure it in a way that the f.d.a. could new products that are less harmful. and the harm reduction center actually has two responsibilities. one, it's to regulate the entire tobacco industry.

Richard Burr: and, two, to facilitate smokers to reduce the harm that potentially can be i'm going to speak later t as i introduce the substitute that i hope every member will take the opportunity to read on behalf of senator hague enand myself. -- senator

Richard Burr: i'm sure we'll both speed throughout the tomorrow. it's my hope that we'll take the opportunity to review the substitute. let me put members on notoriety now. some will come to the floor and claim w that the "help" committee considered and they rejected it 12-8, 13-8, i can't rember exactly what it was.

Richard Burr: let me put members on notice before they come down here and make claims on it. it is not the same bill. it is so i'm sure now staff is going to scramble to figure out what's in#? this new bill. we listened to criticism where we thought we could better the bill, we did that. and the fact is that there are still going to be members that come and make claims tonight,

Richard Burr: tomorrow, before this is all settled that aren't accurate. i put them on notice now, come to the floor, i'll exactly what you say. this is not a debate that we're going to use the charts that we had ten years ago and say that they're relevant today. this is not a debate where we're going to have information that was produced in 1990 for an

Richard Burr: debating in 2009. it's just not right to do that to the american people. and in concluding, colleagues here wanting to speak, i pointed out earlier that in 1998, the industry made a massive payment to 50 states in this country. it was called the master

Richard Burr: settlement agreement, $280 billion that the industry over a fixed period of time was paying out to states, and it was for two purposes. number one, to subsidize the health care costs, the medicaid costs in states that might have been the direct cause of tobacco usage.

Richard Burr: have the resources they needed to create cessation programs so people would move from this category to this category or quit tobacco use i contamine to the floor yesterday, and i'll say for the purposes of the president of the senate, who's from illinois, c.d.c. made recommendations to every state -- they do this every year -- how much of the money that they got that year

Richard Burr: have a prevalence to smoking way too high. in illinois, though, 43.7% have a prevalence to alcohol use. in illinois, 20.3% have a prevalence of marijuana use. now, i'm not picking on the president of the senate and i'm certainly not p illinois.

Richard Burr: i've -- i will have used all 50 states before this is over with. and as i said, one of the shocking things to me was as i explored this chart, i found that i believe it was 48 out of 50 states had a higher youth prevalence of marijuana use than of smoking well, some are going to claim

Richard Burr: that the reason you've got to give f.d.a. jurisdiction over this is that the age limitations of 18 aren't working, that youth are getting the products well, you know what? there's no age where it's legal to buy marijuana. especially for youth. yet in 48 out of the 50 states,

Richard Burr: the prevalence of marijuana usage is higher than the prevalence of smoking. don't believe for a minute that you're going to construct a regulatory regimen here that's going to take legal to people over 18 and is going to allow a framework where

Richard Burr: people under 18 aren't going to get it. when a higher percentage of them can get a product that is illegal for everybody in america america -- and i might also add to the senate president, his state's not the lowest fro standpoint of the percentage that they chose of the c.d.c. recommendation to devote to

Richard Burr: cessation programs. as a matter of fact, one had a commitment of 3.7%. now, $280 billion paid for by the tobacco industry to cover health care costs and i cessation programs. i would suggest to you, if the states

Richard Burr: what the cdc told them to spent, we wouldn't be here talking tobacco industry, because i ?h cessation programs will work and the rate of 19.6% today of smokers would have reduced drastic. i would remind you that the c.d.c. says if we do nothing, but 2016 we reduce the rate to 15.7% of the american people.

Richard Burr: we do nothing, we get to $15.7% f. we pass this bill, we get to 17.5%. if the smokers, we should do nothing. not senator hagan and i will come to the floor want to suggest to our -- not to suggest to our colleagues that we do nothing but to suggest to our colleagues that we do the right thing, that we find the

Richard Burr: appropriate place to put regulation, that we give it the same teeth that the fab fab has, that we give them the ability not just to have black and print advertising, like the kennedy bill z. i i snug my bill that we limb

Richard Burr: adverting, we do away in total. we don't say magazine, which is meant for adult women, may be looked at by an 18-year-old. the kennedy amendment bans it to black and white. we ban is in total. if members will take advantage of reading the look at the substitute, to read

Richard Burr: the base bill, they'll find out we have more regular laying. we actually accomplish -- more regulation. we actually accomplish the task of reducing disease and death. i know that by some of the things that we do, we actually reduce the amount of youth usage on things like eliminating print ads. but there's a big difference. i don't turn it over to the

Richard Burr: f.d.a., and i don't do that for shelfish reasons. purely selfish. i spent 2 1/2 years 15 years ago when i got to the united states house of representatives, where i was tasked by the chairman of the energy and commerce committee to write a bill that modernized the food and drug administration 78. it took 2 1/2 years to do. it was signed into law in 1998.

Richard Burr: we opened up the entirety of the food and drug administration and revamped all the ways that it worked to make sure we could reach new efficiencies in the approval of lifesaving drugs, biologics, which were new, devices we spent a meticulous amount of

Richard Burr: time going through this with one goal in mind. don't lower the gold standard that the american people come to expect through f.d.a. don't lower the sander that an applican we can assure safety and efficacy of the products that we regulate. well, i thought that was

Richard Burr: important, and became law. and do you know what? when we had the entirety of the f.d.a. bill open to every member of the house and the senate, no member of amendment to give the f.d.a. authority over tobacco because they knew at the time that the integrity of the f.d.a. was more

Richard Burr: important than who controlled it from a regulatory standpoint. they didn't want to jeopardize the integrity of what the f.d.a. core mission was. but here now 11 years later -- and i might also sark the sprek ruled in "court case that the f.d.a. didn't have jurisdiction over tobacco.

Richard Burr: and the reason that they chose was in 1998, the congress opened the f.d.a. act and didn't give f.d.a. therefore, it was not thentent of congress for f.d.a. to have authority. so those that claim that this i part of the f.d.a., should have been always would that's not the case.

Richard Burr: because members of glees the opportunity and didn't do it. why? because of the integrity of the food and drug administrationment why in theorld would we have changed in 11 years so where we would risk the gold standard of drug medical devices, why would we risk at a time wherever year for

Richard Burr: the past three years, we've had an issue on food safety, we've had salmonella in peanut but, we've had tainted spinach. we've killed americans yet the agency agency is the agency response responsible for food seavment. why would we dump on an agency today that's struggling to meet

Richard Burr: thr core mission of food safety, a tobacco? why would we take an agency like the f.d.a. that regulates 25 cents of every dollar of the u.s. economy and say what? you've never regulated tobacco before but we'd like to you do

Richard Burr: it now. we'd like to reviewers approving lifesaving drugs, and we'd like to you move them over to the tobacco area. what in the world are we to do? you've never had people at the f.d.a. that have regulated tobacco so they're going to take the most senior folks. so what's the likelihood?

Richard Burr: we're not going to increase chronic disease becau applications won't be acted on. and heaven foregid we do this, and a of a sudden somebody dies as a result of an fab fab reviewer that looked at and it said, well, you know, our core mission is to approve the safety

Richard Burr: and efficacy of all exception of dean because you can't prove it's safe and effect i have. so if i'm going to turn my head on tab corks maybe i'll turn my head on this tobacco device because it doesn'took too bad and aifl sudden somebody dies from it. this is a huge mistake for the united states senate to do. i urge my colleagues, vote for the bill. you won't vote for it. read the statute. it will provide a sufficient

Richard Burr: amount of regulation to an industry that can be better regulated, should be better regulated, more upon thely, a substitute that goes much further from a standpoint of which g and disease. in fact, the substitute is the only bill that accomplishes what the authorities of the current base bill suggest is the reason

Richard Burr: that we're here debating this issue. this chart proves it. it doesn't -- does it in the most visual way. allow these products to come, we've now locked into that's not what the authors suggest is the